Table of Contents
- Foreword
- Executive Summary
- Overview
- Leading Generic Markets
- Injectables
- Major Therapeutic Areas
- Leading Companies and Competition
- Cancer Injectables
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Prostate Cancer
- FDA Approved Generics
- Hormonal Therapies
- Faslodex (fulvestrant)
- Zoladex (goserelin)
- Patents
- Generic Company Activity
- Market Outlook
- Lupron Depot (leuprolide)
- Patents
- Generic Company Activity
- Market Outlook
- Eligard (leuprolide)
- Chemotherapy
- Taxotere (docetaxel)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Abraxane (paclitaxel protein-bound particles for injectable suspension;
albumin-bound)
- Patents
- Generic Company Activity
- Market Outlook
- Camptosar (irinotecan)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Eloxatin (oxaliplatin)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Gemzar (gemcitabine)
- Patents
- Generic Company Activity
- Market Outlook
- Alimta (pemetrexed)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Somatostatin Analogue
- Sandostatin (octreotide acetate)
- Patents
- Generic Company Activity
- Market Outlook
- Targeted Therapy
- Rituxan/MabThera (rituximab)
- Biosimilar Activity
- Market Outlook
- Supportive Therapies
- Zometa/Aclasta/Reclast (zoledronic acid)
- FDA Alert on Bisphosphonates
- Patents
- Market Outlook
- Kytril (granisetron)
- Patents
- Generic Company Activity
- Market Outlook
- G-CSF
- Biosimilar Activity
- CHMP issues positive opinion for biosimilar filgrastim
- Apotex
- Insmed
- Abraxis/Biocon
- EMEA Guidelines for Recombinant Granulocyte-Colony Stimulating Factor
- Neupogen (filgrastim)
- Neulasta (pegfilgrastim)
- Neutrogin/Granocyte (lenograstim)
- Leukine (sargramostim)
- Erythropoietin
- Biosimilar Activity
- EMEA recommendation of new warning for EPO in cancer patients
- Epogen/Eprex (epoetin alpha)
- Aranesp (darbepoetin alpha)
- NeoRecormon/Epogin (epoetin beta)
- Injectable Anti-infectives
- FDA Approved Generics
- Merrem (meropenem)
- Patents
- Generic Company Activity
- Market Outlook
- Zosyn (piperacillin+tazobactam)
- Patents
- Generic Company Activity
- Market Outlook
- Primaxin (imipenem+cilastatin sodium)
- Patents
- Generic Company Activity
- Market Outlook
- Levaquin (levofloxacin)
- Patents
- Generic Company Activity
- Market Outlook
- Cancidas (caspofungin acetate)
- Interferon alpha
- Biosimilar Activity
- EMEA issues draft guidelines for biosimilar interferon alpha
- Intron A (interferon alpha-2b)
- PegIntron (peginterferon alpha-2b)
- Pegasys (pegylated-40K interferon alpha-2a)
- CNS Injectables
- FDA Approved Generics
- Tentative approval for sumatriptan
- Multiple Sclerosis
- Copaxone (glatiramer)
- Patents
- Generic Company Activity
- Market Outlook
- Interferon beta
- Biosimilar Activity
- Avonex (interferon beta-1a)
- Market Outlook
- Rebif (interferon beta-1a)
- Betaferon/Betsaseron (interferon beta-1b)
- Schizophrenia
- Abilify (aripiprazole)
- Patents
- Generic Company Activity
- Market Outlook
- Risperdal (risperidone)
- Patents
- Generic Company Activity
- Market Outlook
- Zyprexa (olanzapine)
- Patents
- Generic Company Activity
- Market Outlook
- Cardiovascular Injectables
- FDA Approved Generics
- Lovenox (enoxaparin)
- Patents
- Generic Company Activity
- Market Outlook
- Arixtra (fondaparinux)
- Patents & Exclusivity
- Generic Company Activity
- Market Outlook
- Integrilin (eptifibatide)
- Angiomax (bivalrudin)
- Endocrine Disorders
- Recombinant Insulin & Insulin Analogues
- Biosimilar Activity
- EMEA Guidelines for Recombinant Human Insulin
- Humulin (insulin human [rDNA origin])
- Humalog (insulin lispro)
- Lantus (insulin glargine)
- Novo Nordisk' s insulin analogues
- Levemir (insulin detemir)
- NovoRapid/NovoLog (insulin aspart [rDNA origin])
- NovoMix/NovoLog Mix
- Recombinant Human Growth Hormone
- Biosimilar Activity
- Sandoz
- BioPartners
- Cangene
- Teva
- EMEA Guidelines for Somatropin
- Genotropin
- Humatrope
- Norditropin
- Nutropin
- Saizen/Serostim
- Company Profiles
- Amphastar Pharmaceuticals
- Injectable Products
- Proposed generic enoxaparin
- Apotex
- Injectable Products
- Financials
- Relevant Agreements
- Apotex to develop biosimilar G-CSF with IBP
- Orchid Chemicals & Pharmaceuticals
- BioGeneriX
- APP Pharmaceuticals
- Products
- Financials
- Major Developments
- Abraxis Bioscience Demerger
- Abraxis acquisition of AstraZeneca' s US anaesthetic and analgesic
injectable products
- Baxter
- Generic Injectable Products
- Financials
- Major Developments
- Acquisition of ESI Lederle
- Bedford Laboratories
- Products
- Sales
- Agreements
- Hikma Pharmaceuticals
- Injectable Products
- Financials
- Major Developments
- Acquisition of Egypt' s Alkan Pharma
- Acquisition of Thymoorgan
- Acquisition of Ribosepharm
- Hospira
- Products
- Financials
- Major Developments
- Mayne Pharma acquisition
- Hikma Pharmaceuticals agreement
- Orchid Chemicals & Pharmaceuticals
- Products
- Financials
- Major Developments
- Orchid forms Japanese subsidiary
- Relevant Agreements
- Strategic alliance with Ranbaxy
- Actavis agreement
- Apotex agreement
- Acquisitions & Joint Ventures
- Bexel Pharmaceuticals Inc.
- Biotechnological Chemical Development Ltd.
- Mano Pharmaceuticals & Sali Healthcare
- NCPC Orchid Pharmaceuticals Ltd.
- Paddock Laboratories
- PharmaForce
- Sagent Pharmaceuticals
- Major Developments
- Agreement with Astral
- Agreement with Strides Arcolab
- Co-promotion agreement with Anesiva
- Sandoz
- Products
- Financials
- Major Developments
- Sandoz receives regulatory guidance on enoxaparin ANDA
- Collaboration with Momenta Pharmaceuticals
- Sun Pharma
- Products
- Financials
- Major Developments
- Able Laboratories acquisition
- Caraco equity stake
- Teva Pharmaceutical Industries
- Products
- Financials
- Major Developments
- Relevant Patent Litigation
- IVAX acquisition
- Sicor acquisition
- Wockhardt
- Injectable Products
- Financials
- Major Developments
- Morton Grove acquisition
- Wockhardt acquires France' s Negma Laboratories
- Appendix I: FDA ANDA Approvals
- Appendix II: UK Injectable Generic Approvals
- SOURCES
List of Tables
- US Patent Expiry for Major Injectable Drugs
- Injectables with Eight or More Generic Competitors in the US Market
- FDA Approved Generic Cancer Injectables, 2003-2008
- Faslodex Sales 2003-2007 (US$ Million)
- Faslodex US Patents
- Zoladex Sales, 2003-2007 (US$ Million)
- Zoladex US Patents
- Lupron Depot/Leuplin Sales, 2003-2007E (US$ Million)
- Lupron Depot US Patents
- FDA ANDA Approvals for Leuprolide
- Eligard US Patents
- Taxotere Sales, 2003-2007 (EUR & US$ Million)
- Taxotere US Patents
- Abraxane Sales, 2005-2007 (US$ Million)
- Abraxane US Patents
- FDA ANDA Approvals for Paclitaxel, 2002-2008
- Camptosar Sales, 2003-2007 (US$ Million)
- Camptosar US Patents
- FDA ANDA Approvals for Irinotecan
- Eloxatin Sales, 2003-2007 (EUR & US$ Million)
- Eloxatin US Patents
- Gemzar Sales, 2003-2007 (US$ Million)
- Gemzar US Patents
- Tentative ANDA Approvals for Gemcitabine
- Alimta Sales, 2004A-2013E (US$ Million)
- Alimta US Patents
- Sandostatin Sales, 2003-2007 (US$ Million)
- Sandostatin US Patents
- FDA ANDA Approvals for Octreotide Acetate
- Sandostatin Sales, 2003A-2013E (US$ Million)
- Rituxan/MabThera Sales, 2003-2007 (US$ Million)
- Zometa Sales, 2003-2007 (US$ Million)
- Zometa US Patents
- Kytril Sales, 2003-2007 (SFr & US$ Million)
- Kytril US Patents
- FDA ANDA Approvals for Granisetron Injection
- Neupogen Sales, 2003-2007 (US$ Million
- Neulasta Sales, 2003-2007 (US$ Million)
- Neutrogin/Granocyte Sales, 2003-2007 (¥ Billion & US$ Million)
- Epogen/Eprex Sales, 2003-2007 (US$ Million)
- Amgen' s Erythropoietin US Patents
- Aranesp Sales, 2003-2007 (US$ Million)
- NeoRecormon/Epogin Sales, 2003-2007 (¥ Billion & US$ Million)
- FDA Approved Generic Anti-infective Injectables, 2003-2008
- Merrem Sales, 2003-2007 (US$ Million)
- Meropen Sales, 2003-2007 (¥ Billion & US$ Million)
- Zosyn Sales, 2003-2007 (US$ Million)
- Primaxin Sales, 2003-2007 (US$ Million)
- Levaquin/Floxin Sales, 2003-2007 US$ Million)
- Cravit Sales, 2004-2008 (¥ Million & US$ Million)
- Levaquin US Patent
- Tentative ANDA Approvals for Levofloxacin Injection
- Cancidas Sales, 2003-2007 (US$ Million)
- Cancidas US Patents
- Intron A Sales, 2003-2007 (US$ Million)
- PegIntron Sales, 2003-2007 (US$ Million)
- Pegasys Sales, 2003-2007 (SFr & US$ Million)
- FDA Approved Generic CNS Injectables, 2003-2008
- Tentative ANDA Approvals for Sumatriptan Injection
- FDA ANDA Approvals for Mitoxantrone
- Copaxone Sales, 2003-2007 (EUR & US$ Million)
- Copaxone US Patents
- Avonex Sales, 2003-2007 (US$ Million)
- Rebif Sales, 2003-2007 (EUR & US$ Million)
- Betaferon/Betaseron Sales, 2003-2007 (EUR & US$ Million)
- Abilify Sales, 2003-2007 (US$ Million)
- Abilify Injection US Patents
- Risperdal Sales, 2003-2007 (US$ Million)
- Risperdal Consta US Patents
- Zyprexa Sales, 2003-2007 (US$ Million)
- Zyprexa Injection US Patent
- FDA Approved Generic Cardiovascular Injectables, 2003-2008
- Lovenox/Clexane Sales, 2003-2007 (EUR & US$ Million)
- Lovenox US Patents
- Arixtra Sales, 2004-2007 (£ & US$ Million)
- Integrilin Sales, 2003-2007 (US$ Million)
- Integrilin US Patents
- Angiomax Sales, 2003-2007 (US$ Million)
- Angiomax US Patent
- Humulin Sales, 2003-2007 (US$ Million)
- Humalog Sales, 2003-2007 (US$ Million)
- Humalog US Patents
- Lantus Sales, 2003-2007 (EUR & US$ Million)
- Lantus US Patents
- Novo Nordisk Insulin Analogue Sales, 2003-2007 (DKr & US$ Million)
- Levemir US Patents
- NovoLog US Patents
- NovoMix 70/30 US Patents
- Genotropin Sales, 2003-2007 (US$ Million)
- Genotropin US Patents
- Humatrope Sales, 2003-2007 (US$ Million)
- Novo Nordisk Growth Hormone Therapy Sales, 2003-2007 (DKr & US$ Million)
- Norditropin US Patents
- Nutropin/Protropin Sales, 2003-2007 (SFr & US$ Million)
- Nutropin US Patent
- Saizen & Serostim Sales, 2003-2007 (EUR & US$ Million)
- Amphastar ANDA Approval
- International Medication Systems ANDA Approvals, 2002-2005
- Apotex ANDA Approvals for Injectables, 2002-2008
- Cangene Financial Results, 2003-2007 (C$ Million)
- APP ANDA Approvals, 2002-2008
- APP Financial Results, 2003-2008 (US$ Million)
- Baxter ANDA Approvals for Injectables, 2002-2008
- Baxter Financial Results, 2003-2007 (US$ Million)
- Bedford Laboratories ANDA Approvals, 2002-2008
- Bedford Laboratories Sales, 2005-2007 (EUR & US$ Million)
- Hikma ANDA Approvals for Injectables, 2002-2008
- Hikma Financial Results, 2004-2007 (US$ Million)
- Hospira ANDA Approvals, 2004-2008
- Abbott ANDA Approvals for Injectables, 2002-2004
- Hospira Tentative ANDA Approval
- Hospira Financial Results, 2003-2007 (US$ Million)
- Orchid Healthcare ANDA Approvals for Injectables, 2005-2008
- Orchid: Financial Results, 2003-2007
- Paddock Laboratories ANDA Approvals, 2003-2006
- PharmaForce ANDA Approvals for Injectables, 2002-2008
- Approved ANDAs Acquired From Spectrum Pharmaceuticals
- Sandoz ANDA Approvals for Injectables, 2005-2008
- Sabex ANDA Approvals, 2003-2005
- Eon Labs ANDA Approval for Injectable, 2005
- Biochemie ANDA Approval for Injectable, 2002
- Sandoz financial results, 2003-2007 (US$ Million)
- Sun Pharma ANDA Approvals for Injectables
- Sun Pharma Tentative ANDA Approval for Injectable
- Sun Pharma: Financial Results, 2003-2007
- Teva Parenteral ANDA Approvals, 2002-2008
- Teva Pharmaceuticals ANDA Approvals for Injectables, 2006
- Pharmachemie ANDA Approvals for Injectables, 2004-2007
- Teva Financial Results, 2003-2007 (US$ millions)
- Wockhardt ANDA Approvals for Injectables
- Wockhardt Financial Results, 2003-2007 (Rs & US$ Million)
- FDA ANDA Approvals for Injectable Drugs, 2006-2008
- Appendix II: UK MHRA Injectable Generic Approvals, 2006-2007
List of Figures
- Generic Pharmaceutical Expenditure, 2007 (US$ billions)
- Generic Pharmaceutical Expenditure per capita, 2007 (US$)
- Generic Pharmaceutical Expenditure as % of Total, 2007
- FDA ANDA Approvals by Therapeutic Area, 2003-2008
- FDA ANDA Approvals by Therapeutic Area, 2003-2008 (%)
- FDA ANDA Approvals by Company 2003-2008
- Competition for Generic Injectables
- Regional Cancer Deaths as % of Total Deaths
- Faslodex Sales, 2003A-2013E (US$ Million
- Zoladex Sales, 2003A-2013E (US$ Million)
- Lupron Sales, 2003A-2013E (US$ Million)
- Taxotere Sales, 2003A-2013E (US$ Million)
- Abraxane Sales, 2005A-2013E (US$ Million)
- Camptosar Sales, 2003A-2013E (US$ Million)
- Eloxatin Sales, 2003A-2013E (US$ Million)
- Gemzar Sales, 2003A-2013E (US$ Million)
- Alimta Sales, 2004A-2013E (US$ Million)
- Rituxan/MabThera Sales, 2003A-2013E (US$ Million)
- Zometa/Aclasta/Reclast Sales, 2003A-2013E (US$ Million)
- Kytril Sales, 2003A-2013E (US$ Million)
- Neupogen Sales, 2003A-2013E (US$ Million)
- Neulasta Sales, 2003A-2013E (US$ Million)
- Neutrogin/Granocyte Sales, 2003A-2013E (US$ Million)
- Epogen/Eprex Sales, 2003A-2013E (US$ Million)
- Aranesp Sales, 2003A-2013E (US$ Million)
- NeoRecormon/Epogin Sales, 2003A-2013E (US$ Million)
- Merrem/Meropen Sales, 2003A-2013E (US$ Million)
- Zosyn Sales, 2003A-2013E (US$ Million)
- Primaxin Sales, 2003A-2013E (US$ Million)
- Levofloxacin Injection Sales, 2003E-2013E (US$ Million)
- Cancidas Sales, 2003A-2013E (US$ Million)
- Intron-A Sales, 2003A-2013E (US$ Million)
- PegIntron Sales, 2003A-2013E (US$ Million)
- Pegasys Sales, 2003A-2013E (US$ Million)
- Copaxone Sales, 2003A-2013E (US$ Million)
- Avonex Sales, 2003A-2013E (US$ Million)
- Rebif Sales, 2003A-2013E (US$ Million)
- Betaferon/Betaseron Sales, 2003A-2013E (US$ Million)
- Abilify Sales (all formulations), 2003A-2013E (US$ Million)
- Risperdal Consta Sales, 2007A-2013E (US$ Million)
- Zyprexa Sales (all formulations), 2003A-2013E (US$ Million)
- Lovenox Sales, 2003A-2013E (US$ Million)
- Arixtra Sales, 2004A-2013E (US$ Million)
- Integrilin Sales, 2003A-2013E (US$ Million)
- Angiomax Sales, 2003A-2013E (US$ Million)
- Humulin Sales, 2003A-2013E (US$ Million)
- Humalog Sales, 2003A-2013E (US$ Million)
- Lantus Sales, 2003A-2013E (US$ Million)
- Novo Nordisk Insulin Analogue Sales, 2003A-2013E (US$ Million)
- Genotropin Sales, 2003A-2013E (US$ Million)
- Humatrope Sales, 2003A-2013E (US$ Million)
- Novo Nordisk Growth Hormone Therapy Sales, 2003A-2013E (US$ Million)
- Nutropin/Protropin Sales, 2003A-2013E (US$ Million)
- Saizen/Serostim Sales, 2003A-2013E (US$ Million)
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